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NIH to Fund Studies on the Clinical Utility of Extracellular RNA for Biomarker Development

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The National Institutes of Health announced last week that the National Institute of Neurological Disorders and Stroke (NINDS) on behalf of the NIH Common Fund Program on Extracellular RNA Communication will support studies that promote the identification and validation of extracellular RNA (exRNA)-based biomarkers readily available from human body fluids and to facilitate the assessment and qualification of biomarkers for their utility in the clinical setting.

Recent studies suggest that exRNAs have both protective and pathogenic roles in a variety of human diseases, and may also explain observed associations between environmental exposures and health or disease. As such, the goal of this FOA is to promote the identification and validation of exRNA-based biomarkers readily available from human body fluids, such as serum, plasma, saliva, urine, semen, breast milk, amniotic fluid, cerebrospinal fluid, ascites and bronchoalveolar lavage fluid, and to facilitate the assessment and qualification of biomarkers for their utility in the clinical setting.

NIH funds will be made available through the UH2/UH3 cooperative agreement award mechanism, which is designed to support the development of new research activities in categorical program areas. The initial UH2 phase will support 1-2 year studies to identify and develop exRNA-based biomarkers from human body fluids. The UH3 phase will support the transition to qualification and validation studies in the remaining 3-4 years. The maximum period of support for the combined UH2 and UH3 phases is 5 years. Awards funded under this FOA are anticipated to involve activities conducted by multidisciplinary teams of investigators.

The UH2/UH3 phases must be submitted as a single application but the approach should be clearly organized into two stages: UH2 (phase 1) and UH3 (phase 2). During the UH2 phase, support will be provided for proof of principle studies to develop biomarkers that correlate with biological function, disease states or response to treatment, and are readily available from existing human biofluid specimen collections. The proposed studies should include the comparative analysis of exRNAs produced from healthy vs patients. Following NIH administrative review, the UH3 phase will build upon successful UH2 projects and support qualification and validation studies wherein the biomarker has been demonstrated during the UH2 phase to reliably support a specified manner of interpretation and application in its declared “context of use (CoU)”.

Letters of intent are due by October 12, 2012 and applications are due November 13, 2012.

The UH2 phase will support between 6-8 awards with up to $500,000 in total costs. Following administrative review, UH2 awardees who have met their milestones will be eligible to transition to the UH3 phase that will provide up to $1,000,000 in total costs.

FOA: RFA-RM-12-013: Clinical Utility of Extracellular RNA for Biomarker Development (UH2/UH3)

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